Aziyo Biologics Presents Positive Clinical Data on CanGaroo® Biologic Envelope
19 May 2023 - 10:15PM
Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that
develops and commercializes biologic products to improve
compatibility between medical devices and the patients who need
them, today announced that positive data from the HEAL Study will
be presented at Heart Rhythm Society (HRS 2023) on May 21, 2023, at
12:30 PM CT at the Morial Convention Center in New Orleans, LA.
HEAL is a national multi-center study evaluating
patients who previously underwent implantation of a cardiac
implantable electronic device (CIED) with either an Aziyo CanGaroo®
Envelope, Medtronic’s Tyrx™ non-biologic envelope, or no envelope,
and are returning for a revision procedure at least four months
after initial placement. The CanGaroo Envelope is made of an
acellular biologic matrix that is designed to promote a natural
healing response, resulting in a healthy, vascularized tissue
capsule.
“The HEAL data further support the potential of
biologic envelopes to enhance pocket healing during CIED
implantation and simplify reoperative procedures,” said John N.
Catanzaro, M.D., Associate Professor of Medicine with the
University of Florida and lead investigator of the study. “This
study demonstrates that biologic envelopes, such as CanGaroo, can
improve patient care and decrease complications following device
implantation.”
The poster to be presented at HRS 2023 comprises
data from 43 patients (CanGaroo, n=11, Tyrx, n=15, or no envelope,
n=17) used with their initial CIED implantation. This interim
analysis includes the evaluation of medical and clinical profiles,
procedural notes and physician subjective scoring of the pocket,
and histology.
Key findings from the interim analysis
include:
- Physicians
scored CanGaroo reoperations as having 46% easier generator
mobilization (p=.02), 41% easier lead mobilization (p=.01), and 43%
less overall procedural difficulty (p=.04) compared to no
envelope.
- Lead adhesion classification was
scored as significantly less severe in the CanGaroo group compared
to no envelope (p=.003).
- Significantly fewer capsulectomy
procedures were required in the CanGaroo vs. Tyrx group (83% less,
p=.04).
- Independent, blinded histologic
evaluation of pocket biopsies showed 30% thinner capsules in
CanGaroo implant pockets vs. no envelope (p=0.12) and 32% thinner
capsules vs. Tyrx (p=.09).
- No significant
group differences were observed in mean age, gender, race, or prior
implant history.
Abstract and presentation
details:
-
Abstract Title: Biologic Cardiovascular Electronic
Device Envelopes Enhance Pocket Healing and Simplify Reoperative
Procedures
-
Presenter: Dr. John N. Catanzaro, MD, MBA, FACC,
FESC, FHRS, Department of Cardiology, University of Florida Health,
Jacksonville, FL
-
Date: Sunday, May 21, 2023 at 12:30 PM – 2:30 PM
Central Time
-
Location: Abstract Pavilion - Morial Convention
Center
During the event, Aziyo Biologics will be exhibiting at Booth
319.
About Aziyo Biologics
Aziyo develops and commercializes biologic
products to improve compatibility between medical devices and the
patients who need them. With a growing population in need of
implantable technologies, Aziyo’s mission is to humanize medical
devices to improve patient outcomes. For more information, visit
www.Aziyo.com.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Forward-looking statements can be identified
by words such as “projects,” “may,” “will,” “could,” “would,”
“should,” “believes,” “expects,” “anticipates,” “estimates,”
“intends,” “plans,” “potential,” “promise” or similar references to
future periods. All statements contained in this press release that
do not relate to matters of historical fact should be considered
forward-looking statements, including statements and information
concerning the effectiveness of the CanGaroo RM Antibacterial
Envelope and its potential to improve CIED implantation patient
care and reduce complications following implantation.
Forward-looking statements are based on management’s current
assumptions and expectations of future events and trends, which
affect or may affect our business, strategy, operations or
financial performance, and actual results may differ materially
from those expressed or implied in such statements due to numerous
risks and uncertainties. Forward-looking statements are inherently
subject to risks and uncertainties, some of which cannot be
predicted or quantified, and other important factors that may cause
actual results, performance or achievements to differ materially
from those contemplated or implied in this press release,
including, but not limited to, risks regarding the ability to
successfully execute or realize the anticipated benefits under our
distribution arrangements with LeMaitre Vascular and Sientra; our
inability to generate sufficient revenue to achieve or sustain
profitability; adverse changes in economic conditions and
instability and disruption of credit markets; our ability to
continue as a going concern; our products and our ability to
enhance, expand, develop and commercialize our product offerings;
the impact on our business of the recall of a single lot of our
FiberCel product and the discontinuation of its sales by our
distribution partner; our dependence on our commercial partners;
physician awareness of the distinctive characteristics, and
acceptance by the medical community, of our products; the ability
to obtain regulatory approval or other marketing authorizations;
and our intellectual property rights, and other important factors
which can be found in the “Risk Factors” section of Aziyo’s public
filings with the Securities and Exchange Commission (“SEC”),
including Aziyo’s Annual Report on Form 10-K for the year ended
December 31, 2022, as such factors may be updated from time to time
in Aziyo’s other filings with the SEC, including, Aziyo’s Quarterly
Reports on Form 10-Q, accessible on the SEC’s website at
www.sec.gov and the Investor Relations page of Aziyo’s website at
https://investors.aziyo.com. Because forward-looking statements are
inherently subject to risks and uncertainties, you should not rely
on these forward-looking statements as predictions of future
events. Any forward-looking statement made by Aziyo in this press
release is based only on information currently available and speaks
only as of the date on which it is made. Except as required by
applicable law, Aziyo expressly disclaims any obligations to
publicly update any forward-looking statements, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Investors:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
Media:Courtney GuyerAziyo Biologics,
Inc.PR@aziyo.com
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